Transoral endoscopic gastroesophageal flap valve restoration device, assembly, system and method

ABSTRACT

The invention provides a device, assembly, and method for transoral endoscopic restoration of a gastroesophageal flap valve. The invention also provides a self-steering and self-closing tissue fixation device for tissue fixation, and an invaginator device for gripping and maneuvering tissue. The restoration device includes a longitudinal member arranged for transoral placement into a stomach, a tissue shaper carried on the longitudinal member that causes stomach tissue to assume a shape related to a gastroesophageal flap, and a tissue fixation device that maintains the shaped stomach tissue in a shape approximating a gastroesophageal flap. The tissue shaper may include a mold. The device may include the invaginator device for gripping and maneuvering esophageal tissue to aid restoration of the gastroesophageal flap, and may include the tissue fixation device.

FIELD OF THE INVENTION

The present invention generally relates to a device, assembly, system,and method for treating gastroesophageal reflux disease by restoring thegastroesophageal flap valve. The present invention more particularlyrelates to restoring the gastroesophageal flap valve by drawing gastrictissue into a shape approximating a normal gastroesophageal flap andfixing the tissue into that shape.

BACKGROUND

Gastroesophageal reflux disease (GERD) is a chronic condition caused bythe failure of the anti-reflux barrier located at the gastroesophagealjunction to keep the contents of the stomach from splashing into theesophagus. The splashing is known as gastroesophageal reflux. Thestomach acid is designed to digest meat, and will digest esophagealtissue when persistently splashed into the esophagus.

FIG. 1 is a front cross-sectional view of theesophageal-gastro-intestinal tract 40 from a lower portion of theesophagus 41 to the duodenum 42. The stomach 43 is characterized by thegreater curvature 44 on the anatomical left side and the lessercurvature 45 on the anatomical right side. The fundus 46 of the greatercurvature 44 forms the superior portion of the stomach 43, and traps gasand air bubbles for burping. The esophageal tract 41 enters the stomach43 at a point below the superior portion of the fundus 46, forming acardiac notch 47 and an acute angle with respect to the fundus 46 knownas the Angle of His 57. The lower esophageal sphincter (LES) 48 is adiscriminating sphincter able to distinguish between burping gas,liquids, and solids, and works in conjunction with the fundus 46 toburp. The gastroesophageal flap valve (GEFV) 49 includes a moveableportion and an opposing more stationary portion. The moveable portion ofthe GEFV 49 is an approximately 180 degree, semicircular,gastroesophageal flap 50 (alternatively referred to as a “normalmoveable flap” or “moveable flap”) formed of tissue at the intersectionbetween the esophagus 41 and the stomach 43. The opposing morestationary portion of the GEFV 49 comprises a portion of the lessercurvature 45 of the stomach 43 adjacent to its junction with theesophagus 41. The gastroesophageal flap 50 of the GEFV 49 principallycomprises tissue adjacent to the fundus 46 portion of the stomach 43, isabout 4 to 5 cm long (51) at it longest portion, and the length maytaper at its anterior and posterior ends. The gastroesophageal flap 50is partially held against the lesser curvature 45 portion of the stomach43 by the pressure differential between the stomach 43 and the thorax,and partially by the resiliency and the anatomical structure of the GEFV49, thus providing the valving function. The GEFV 49 is similar to aflutter valve, with the gastroesophageal flap 50 being flexible andcloseable against the other more stationary side.

The esophageal tract is controlled by an upper esophageal sphincter(UES) near the mouth for swallowing, and by the LES 48 and the GEFV 49at the stomach. The normal antireflux barrier is primarily formed by theLES 48 and the GEFV 49 acting in concert to allow food and liquid toenter the stomach, and to considerably resist reflux of stomach contentsinto the esophagus 48 past the gastroesophageal tissue junction 52.Tissue aboral of the gastroesophageal tissue junction 52 is generallyconsidered part of the stomach because the tissue protected from stomachacid by its own protective mechanisms. Tissue oral of thegastroesophageal junction 52 is generally considered part of theesophagus and it is not protected from injury by prolonged exposure tostomach acid. At the gastroesophageal junction 52, the juncture of thestomach and esophageal tissues form a zigzag line, which is sometimesreferred to as the “Z-line.” For the purposes of these specifications,including the claims, “stomach” means the tissue aboral of thegastroesophageal junction 52. As pressure in the stomach 43 increases,the pressure tightly closes the normal gastroesophageal flap 50 of theGEFV 49 against the lesser curve portion 45 of the stomach. The tissuesare tightly opposed preventing reflux. The stomach 43 provides forburping by the diaphragm 53 pushing down on and flattening the fundus46, temporarily resulting in the cardiac notch 47 being straightened andthe Angle of His 57 becoming less acute. The normal gastroesophagealflap 50 of the GEFV 49 opens to allow the burp to pass into theesophagus 41.

FIG. 2 is a front cross-sectional view of theesophageal-gastro-intestinal tract 40 illustrating a Grade I normalappearance movable flap 50 of the GEFV 49 and a Grade IV refluxappearance gastroesophageal flap 55 of the GEFV 49. A principal reasonfor regurgitation associated with GERD is the mechanical failure of thedeteriorated (or reflux appearance) gastroesophageal flap 55 of the GEFV49 to close and seal against the high pressure in the stomach. Due toreasons including lifestyle, a Grade I normal gastroesophageal flap 50of the GEFV 49 may deteriorate into a Grade IV deteriorated (or refluxappearance) gastroesophageal flap 55. The anatomical results of thedeterioration include moving a portion of the esophagus 41 that includesthe gastroesophageal junction 52 and LES 48 toward the mouth,straightening of the cardiac notch 47, and increasing the Angle of His57. This effectively reshapes the anatomy aboral of the gastroesophagealjunction 52 and forms a flattened fundus 56. The deterioratedgastroesophageal flap 55 illustrates a gastroesophageal flap valve 49and cardiac notch 47 that have both significantly degraded. Dr. Hill andcolleagues developed a grading system to describe the appearance of theGEFV and the likelihood that a patient will experience chronic acidreflux. L. D. Hill, et al., The gastroesophageal flap valve: in vitroand in vivo observations, Gastrointestinal Endoscopy 1996:44:541-547.Under Dr. Hill's grading system, the normal movable flap 50 of the GEFV49 illustrates a Grade I flap valve that is the least likely toexperience reflux. The deteriorated gastroesophageal flap 55 of the GEFV49 illustrates a Grade IV flap valve that is the most likely toexperience reflux. Grades II and III reflect intermediate grades of thelikelihood of experiencing reflux. In the Grade IV condition with thedeteriorated GEFV represented by deteriorated gastroesophageal flap 55and the fundus 46 moved inferior, the stomach contents are presented afunnel-like opening directing the contents into the esophagus 41.

With the deteriorated gastroesophageal flap 55, the stomach contents aremore likely to be regurgitated into the esophagus 41, the mouth, andeven the lungs. The LES 48 by itself is relatively weak and does notprovide sufficient resistance to prevent reflux or regurgitation byitself. The regurgitation is referred to as “heartburn” because the mostcommon symptom is a burning discomfort in the chest under thebreastbone. Burning discomfort in the chest and regurgitation (burpingup) of sour-tasting gastric juice into the mouth are classic symptoms ofgastroesophageal reflux disease (GERD). When stomach acid isregurgitated into the esophagus, it is usually cleared quickly byesophageal contractions. Heartburn (backwashing of stomach acid and bileonto the esophagus 41) results when stomach acid is frequentlyregurgitated into the esophagus 41, or if it is not promptly cleared.Chronic heartburn or GERD occurs because of a mechanical failure by thedeteriorated gastroesophageal flap 55 of the GEFV 49 and the LES 48 tokeep stomach acid and digestive juices out of the esophagus 41. The GEFV49 and LES 48 fail to maintain the normally higher pressure in thestomach 43 and keep stomach contents out of the esophagus 41. Peoplewith a normal movable flap 50 may experience occasional transient GEFV49 and LES 48 relaxations that lead to backwashing of stomach contentsonto the esophagus 41. These transient relaxations account for most ofthe gastroesophageal reflux episodes and occasional symptoms in peoplewith a normal gastroesophageal flap 50. However, because thedeteriorated gastroesophageal flap 55 of GEFV 49 and the LES 48 are notmechanically able to maintain the normal pressure in the stomach 43, thestomach contents more readily and regularly bathe the esophagus 41. Theesophageal contractions alone are not strong enough to adequately“strip” the stomach contents out of the esophagus 41, leading toprolonged acid and bile exposure in the esophagus. This prolongedexposure allows injury to the normal squamous lining of the esophagus tooccur, resulting in esophagitis and in some people, healing of theesophagus with the development of a new lining, called Barrett'sesophagus.

Complications develop for some people who have GERD. Esophagitis(inflammation of the esophagus) with erosions and ulcerations (breaks inthe lining of the esophagus) can occur from repeated and prolonged acidexposure. If these breaks are deep, bleeding or scarring of theesophagus with formation of a stricture (narrowing of the esophagus) canoccur. If the esophagus narrows significantly, then food sticks in theesophagus and the symptom is known as dysphagia. GERD has been shown tobe one of the most important risk factors for the development ofesophageal adenocarcinoma. In a subset of people who have severe GERD,if acid exposure continues, the injured squamous lining is replaced byBarrett's metaplasia (Barrett's esophagus), a precancerous lining inwhich esophageal adenocarcinoma can develop. To date, no one knows whatcauses Barrett's esophagus.

Other complications of GERD may not appear to be related to esophagealdisease at all. Some people with GERD may develop recurrent pneumonia(lung infection), asthma (wheezing), or a chronic cough from acidbacking up into the esophagus and all the way up through the upperesophageal sphincter into the lungs. In many instances, this occurs atnight, while the person is sleeping. Occasionally, a person with severeGERD will be awakened from sleep with a choking sensation. Hoarsenesscan also occur due to acid reaching the vocal cords, causing a chronicinflammation or injury.

Deteriorated gastroesophageal flap 55 and GERD never improve withoutintervention. Both medical and surgical treatments exist for GERD.Medical therapies include antacids and proton pump inhibitors. However,the medical therapies only mask the reflux. Patients still get refluxand perhaps emphysema because of particles refluxed into the lungs.Barrett's esophagus results in about 10-15% of the GERD cases. Theesophageal epithelium changes into tissue that tends to become cancerousfrom repeated acid washing despite the medication.

Several open laparotomy and laproscopic surgical procedures areavailable for treating GERD. One surgical approach is the Nissenfundoplication. The Nissen approach typically involves a 360-degree wrapof the fundus around the gastroesophageal junction 52. The procedure hasa high incidence of postoperative complications. The Nissen approachcreates a 360-degree moveable flap without a fixed portion. While Nissenreinforces the LES 48, it does not restore the normal movable flap 50 ofGEFV 49. The patient cannot burp because the fundus 46 was used to makethe repair, and may frequently experience dysphagia. Another surgicalapproach to treating GERD is the Belsey Mark IV (Belsey) fundoplication.The Belsey procedure involves creating a valve by suturing a portion ofthe stomach 43 to an anterior surface of the esophagus 41. It reducessome of the postoperative complications encountered with the Nissenfundoplication, but still does not restore the normal movable flap 50 ofGEFV 49. None of these procedures fully restores the normal anatomicalanatomy or produces a normally functioning gastroesophageal junction.Another surgical approach is the Hill repair. In the Hill repairprocedure, the gastroesophageal junction 52 is anchored to the posteriorabdominal areas, and a 180-degree valve is created by a system ofsutures. The Hill procedure restores the moveable flap 50, the cardiacnotch 47 and the Angle of His 57. However, all of these surgicalprocedures are very invasive, regardless of whether done as alaproscopic or an open procedure.

New, less surgically invasive approaches to treating GERD involvetransoral endoscopic procedures. One procedure contemplates a machinedevice with robotic arms that is inserted transorally into the stomach43. While observing through an endoscope, a endoscopist guides themachine within the stomach 43 to engage a portion of the fundus 46 witha corkscrew-like device on one arm. The arm then pulls on the engagedportion to create a flap of tissue near the deterioratedgastroesophageal flap 55. Another arm of the machine pinches the base ofthe flap, and drives staples and/or sutures through it to secure theflap. The endoscopist engages additional portions of the fundus 46 anddrives additional staples until the endoscopist is satisfied with theflap produced. While the pinch-and-staple procedure may provide ameasure of treatment in appropriate hands, it neither fully restores thenormal gastroesophageal flap valve anatomy nor produces a normallyfunctioning gastroesophageal junction 52. Instead, the procedure onlycreates a tissue bulge that may assist in limiting reflux. Furthermore,this procedure is highly dependent on the skill, experience,aggressiveness, and courage of the endoscopist. A more timid endoscopistmay take only small bites of tissue, and as a result may notsuccessfully create a flap that functions as a normal movable flap 50.Every flap built with this procedure will be different because itdepends so much on the skill and courage of the physician. Anothertransoral procedure contemplates making a fold of fundus tissue near thedeteriorated gastroesophageal flap 55 to recreate the LES. The procedurerequires placing multiple U-shaped tissue clips around the folded fundusto hold it in shape and in place. Like the previously discussedprocedure, this procedure is also highly dependent on the skill,experience, aggressiveness, and courage of the endoscopist. In addition,these and other procedures may involve esophageal tissue in the repair.Esophageal tissue is fragile and weak, and involvement of esophagealtissue in the repair of a gastroesophageal flap valve poses unnecessaryrisks to the patient.

Present and emerging methods all depend on the skill, experience, andaggressiveness of the endoscopist to grasp the appropriate amount ofstomach or esophagus tissue to build the depth and width of thestructure contemplated. This results in non-uniformity from patient topatient and non-uniformity from endoscopist to endoscopist. There is aneed for a highly standardized and uniform device and procedure forrestoring the natural gastroesophageal flap valve and a normallyfunctioning gastroesophageal junction.

In view of the foregoing, there is a need in the art for a new andimproved apparatus and method for restoration of a gastroesophageal flapvalve. The present invention is directed to a device, system, and methodthat provide such an improved apparatus and method for restoration of agastroesophageal flap valve.

SUMMARY

The invention provides a transoral endoscopic gastroesophageal flapvalve restoration device. The device includes a longitudinal memberarranged for transoral placement into a stomach, a tissue shaper carriedon the longitudinal member that causes stomach tissue to assume a shaperelated to a gastroesophageal flap, and a tissue fixation device thatmaintains the shaped stomach tissue in a shape approximating agastroesophageal flap. The tissue shaper may include a tissue gripper.The tissue fixation device may include a self-steering and self-closingdevice having an elongated member having a first end portion and asecond end portion, the first end portion terminating in atissue-piercing end, and a connecting portion extending between thefirst and second end portions, the connecting portion having a first andsecond joining portions separated by a pressure portion. The elongatedmember has an initial stressed and distorted configuration that, as theportions beginning with the first end portion are deployed from a lumenby a force pushing on the second end portion, steers the elongatedmember into and through tissue proximate to the lumen and assumes afinal configuration, wherein the elongated member forms an interiorperimeter holding together tissue enclosed within the perimeter.

The invention further provides a transoral endoscopic gastroesophagealflap valve restoration assembly. The assembly includes a longitudinalmember arranged for transoral placement into a stomach and that carriesa mold having a shape related to a gastroesophageal flap, a tissueshaper that non-invasively grips and urges tissue into the mold, and atissue fixation device that maintains the molded stomach tissue in ashape approximating a gastroesophageal flap. The mold may have a firstconfiguration for transoral placement in proximity to thegastroesophageal junction, and a second configuration having the shaperelated to the gastroesophageal flap valve. The mold may be furtherarranged to move from the first configuration to the secondconfiguration in vivo. The mold may also be further arranged to movefrom the first configuration to the second configuration in response toa change in pressure in a portion of the mold. The mold may have a firstconfiguration for transoral placement in proximity to theesophageal-gastric junction, a second configuration having the shaperelated to the gastroesophageal flap valve, and a third configurationfor transoral removal. The first configuration and third configurationmay be similar. The mold may be made from any biocompatible materialknown in the art, may have a shape related to a gastroesophageal flapthat is transparent. The mold may include a material that is passed “pervias naturales,” including a material that is degradable or digestiblewithin the digestive system and passed out of the body, or simply passedout of the body. The molded stomach tissue may form an approximately 180degree, semicircular structure. In alternative embodiments, the mold maybe configured to form a semicircular structure having with asemicircular arc varying between approximately 90 degrees and 360degrees.

In accordance with a further embodiment of the present invention, thelongitudinal member may include a channel arranged to maintain anorientation with the endoscope. The longitudinal member may be arrangedto at least partially surround a length of an endoscopic device, and bemoveable relative to the length of the endoscopic device. Further, thelongitudinal member may be arranged to engage an extracorporeal portionof a shaft of an endoscopic device when a distal portion of theendoscopic device is in vivo, and be moveable relative to the shaft ofthe endoscopic device. The longitudinal member may include at least onelumen arranged to carry at least one tissue fixation device. Thelongitudinal member may further comprise an extracorporeal memberproviding movement control. The longitudinal member may carry the tissueshaper. The tissue shaper may grip tissue with a vacuum, and may furtherinclude a plurality of vacuum orifices on at least a portion of amolding surface of the mold arranged to draw tissue into the mold andhold the tissue proximate to the molding surface. The tissue shaper mayinclude a structure that moves from a first position arranged to griptissue to a second position arranged to urge tissue into the mold, and amember carried on the structure and having a plurality of vacuumorifices on a surface arranged to grip tissue. The tissue shaper may bemovable with respect to the mold. The fixation device may include aself-steering and self-closing tissue fixation device that includes anelongated member having a first end portion and a second end portion,the first end portion terminating in a tissue-piercing end, and aconnecting portion extending between the first and second end portions,the connecting portion having first and second joining portionsseparated by a pressure portion. The elongated member has an initialstressed and distorted configuration that, as the portions beginningwith the first end portion are deployed from a lumen by a force pushingon the second end portion, steers the elongated member into and throughtissue proximate to the lumen and assumes a final configuration, whereinthe elongated member forms an interior perimeter holding together tissueenclosed within the perimeter. The elongated member of the tissuefixation device may form a substantially enclosed interior perimeterwhen the elongated member is in the final configuration.

The present invention further provides a transoral endoscopicgastroesophageal flap valve restoration assembly. The assembly includesa longitudinal member arranged for transoral placement into a stomachthat carries a mold having a shape related to a gastroesophageal flap, atissue gripper that non-invasively grips with a vacuum and urges tissueto take a shape related to the mold, an invaginator having a tissuegripper to vacuum grip esophageal tissue and allow a force to beimparted to the vacuum gripped esophageal tissue, and a tissue fixationdevice that maintains the molded stomach tissue in a shape approximatinga gastroesophageal flap. The invaginator may have a first configurationfor transoral placement in the esophagus, and a second configuration forvacuum engagement with the esophageal tissue, which may be in responseto a change in pressure in a portion of the invaginator. The invaginatormay be further arranged to move from the first configuration to thesecond configuration in vivo. The invaginator may include anextracorporeal member providing movement control, may be arranged to becarried on an endoscopic device, and may have a channel arranged tomaintain an orientation with an endoscopic device. The invaginator mayalso have a channel arranged to maintain an orientation with the mold.The invaginator may further include a plurality of vacuum orificesopening on at least a portion of the peripheral surface of theinvaginator and arranged to hold tissue proximate to at least a portionof the peripheral surface. The invaginator may allow a force to beimparted to the vacuum gripped esophageal tissue sufficient to movestomach tissue into an improved position for restoration of agastroesophageal flap. The invaginator may be made from anybiocompatible material known in the art.

The invention provides for yet another embodiment providing a transoralendoscopic gastroesophageal flap valve restoration assembly. Theassembly includes a longitudinal member arranged for transoral placementinto a stomach, and that carries a mold having a shape related to agastroesophageal flap. The longitudinal member further has a channelarranged to maintain an orientation with an endoscopic device, and alumen or other type of chamber arranged to carry a tissue fixationdevice. The assembly also includes a tissue gripper that non-invasivelygrips with a vacuum and urges tissue to take a shape related to themold, the tissue gripper including a member carried on the longitudinalmember that has a plurality of vacuum orifices on a surface arranged togrip tissue and hold the tissue proximate to a molding surface of themold. The assembly further includes a self-steering and self-closingtissue fixation device that maintains the molded stomach tissue in ashape approximating a gastroesophageal flap, the tissue fixation devicehaving an elongated member having a first end portion and a second endportion, the first end portion terminating in a tissue-piercing end, anda connecting portion extending between the first and second endportions, the connecting portion having a first and second joiningportions separated by a pressure portion. The elongated member has aninitial stressed and distorted configuration that, as portions beginningwith the first end portion are deployed from a lumen by a force pushingon the second end portion, steers the elongated member into and throughtissue proximate to the lumen and assumes a final configuration, whereinthe elongated member forms an interior perimeter holding together tissueenclosed within the perimeter.

The invention provides for a self-steering and self-closing tissuefixation device for effecting tissue geometry. The tissue fixationdevice includes an elongated member having a first end portion and asecond end portion, the first end portion terminating in atissue-piercing end, and a connecting portion extending between thefirst and second end portions, the connecting portion having a first andsecond joining portions separated by a pressure portion. The elongatedmember has an initial stressed and distorted configuration that, asportions beginning with the first end portion are deployed from a lumenby a force pushing on the second end portion, steers the elongatedmember into and through a fold of tissue proximate to the lumen andassumes a final configuration, wherein the elongated member forms aninterior perimeter holding together the fold of tissue enclosed withinthe perimeter. The elongated member may form a substantially enclosedinterior perimeter when the elongated member is in the finalconfiguration. The first end portion may be proximate to the second endportion when the elongated member is in the final configuration. Theelongated member may form an approximately rectangular interiorperimeter in the final configuration. The elongated member may form anapproximately round interior perimeter in the final configuration. Theelongated member may be formed from material having superelastic andshape memory properties, including Nitinol, or from a plastic materialhaving shape memory.

Still another embodiment of the invention provides an invaginator devicecomprising a member arranged to vacuum grip interior tissue of a hollowbody structure and allow a force to be imparted on the hollow bodystructure. The member may have a first configuration for placement inthe hollow body structure, and a second configuration for vacuumgripping of the hollow body structure. The member may be furtherarranged to move from the first configuration to the secondconfiguration in vivo, which may be in response to a change in pressurein an expandable portion of the device. The invaginator may furthercomprise a plurality of vacuum orifices opening on at least a portion ofthe peripheral surface of the invaginator and arranged to hold tissueproximate to at least a portion of the peripheral surface. Theinvaginator may allow a force to be imparted to the vacuum grippedesophageal tissue sufficient to move stomach tissue into an improvedposition for restoration of a gastroesophageal flap. The invaginator mayinclude an extracorporeal portion providing movement control, may bearranged to be carried on an endoscopic device, and may include achannel arranged to maintain an orientation with an endoscopic device.

In accordance with still yet another embodiment, the present inventionprovides a method of transoral restoration of a gastroesophageal flapvalve. The method includes the steps of selecting a portion ofintraluminal fundus tissue that is proximate to the cardiac notch oranother portion of the gastric wall, shaping the tissue into a shaperesembling a gastroesophageal flap, and fixating the shaped tissue intoa shape approximating a gastroesophageal flap. The fixating step mayinclude deploying a self-steering and self-closing device. The shapingstep may include molding the tissue into a shape resembling agastroesophageal flap.

In another embodiment, the present invention provides a method oftransoral restoration of a gastroesophageal flap valve. The methodincludes the steps of providing at least one self-steering andself-closing tissue fixation device for effecting gastroesophagealgeometry, and providing a longitudinal member carrying a mold having ashape related to a gastroesophageal flap valve, and a tissue shaper thaturges gastric tissue to take a shape related to the mold, the tissuegripper including a member having a plurality of vacuum orifices on asurface arranged to grip tissue and to hold the tissue proximate to amolding surface of the mold. The method further includes the steps ofplacing at least one tissue fixation device into a lumen in thelongitudinal member arranged to carry a tissue fixation device, locatingthe mold proximate to the gastroesophageal junction, gripping gastrictissue from the fundus region of the stomach proximate to the cardiacnotch with the tissue shaper and urging the gastric tissue into a shaperelated to a gastroesophageal flap, and pushing at least one tissuefixation device from the lumen and into the gastric tissue to maintainthe gastric tissue in a shape approximating a gastroesophageal flap. Themethod may further include the step of applying a force with aninvaginator to the vacuum gripped esophageal tissue sufficient to movestomach tissue into an improved position for restoration of agastroesophageal flap.

These and various other features as well as advantages whichcharacterize the present invention will be apparent from a reading ofthe following detailed description and a review of the associateddrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further objects and advantages thereof, may best beunderstood by making reference to the following description taken inconjunction with the accompanying drawings, in the several figures ofwhich like referenced numerals identify like elements, and wherein:

FIG. 1 is a front cross-sectional view of theesophageal-gastro-intestinal tract from a lower portion of the esophagusto the duodenum;

FIG. 2 is a front cross-sectional view of theesophageal-gastro-intestinal tract illustrating a Grade I normalappearance movable flap of the gastroesophageal flap valve and a GradeIV reflux appearance gastroesophageal flap of the gastroesophageal flapvalve;

FIG. 3 is a perspective partial-sectional view of a gastroesophagealflap valve restoration assembly including a mold of the normal movableflap according to an embodiment of the invention;

FIG. 4 is a plan view of a self-steering and self-closing tissuefixation device according to an embodiment of the invention;

FIG. 5 is a side view of the self-steering and self-closing tissuefixation device of FIG. 4 carried in a lumen, and in its initialstressed and distorted configuration;

FIGS. 6-9 illustrate sequential configurations of the self-steering andself-closing tissue fixation device as it is deployed and moves from aninitial configuration to a final configuration;

FIG. 10 is a perspective cross-sectional view of the gastroesophagealflap valve restoration assembly of FIG. 3 being used to transorallyrestore a gastroesophageal flap valve employing an endoscopicvisualization device, according to an embodiment of the invention;

FIG. 11 is a perspective cross-sectional view of a restoredgastroesophageal flap and a restored gastroesophageal flap valveaccording to an embodiment of the invention;

FIG. 12 is a perspective partial cross-section view of an invaginatordevice according to an embodiment of the invention;

FIG. 13 is a perspective cross-sectional view of the gastroesophagealflap valve restoration assembly of FIG. 3 and the invaginator assemblyof FIG. 12 being used to transorally restore a gastroesophageal flapvalve employing an endoscopic visualization device, according to anembodiment of the invention;

FIG. 14 is a perspective partial-sectional view of a gastroesophagealflap valve restoration assembly with a moveable tissue gripper in anextended configuration, according to an embodiment of the invention;

FIG. 15 is a cross-sectional plan view of the mold of FIG. 14;

FIG. 16 is a perspective partial-sectional view of a gastroesophagealflap valve restoration assembly of FIG. 14 with the moveable tissuegripper in a retracted/molding configuration, according to an embodimentof the invention;

FIGS. 17-22 are sequential, schematic cross-sectional views illustratingthe gastroesophageal flap valve restoration assembly of FIGS. 14-16being used to transorally restore a gastroesophageal flap valve,according to an embodiment of the invention;

FIG. 23 is a perspective partial-sectional view of a gastroesophagealflap valve restoration assembly with a tissue gripper guide in itsretracted/molding configuration, according to an embodiment of theinvention;

FIG. 24 is a cross-sectional view illustrating the gastroesophageal flapvalve restoration assembly of FIG. 23 being used to transorally restorea gastroesophageal flap valve, according to an embodiment of theinvention;

FIG. 25 is perspective partial-sectional view of a gastroesophageal flapvalve restoration assembly of FIGS. 14-16 arranged to engage anextracorporeal portion of an endoscopic device when a portion of theendoscopic device is in vivo, according to an embodiment of theinvention; and

FIG. 26 is a perspective partial cross-sectional view ofgastroesophageal flap valve restoration assembly of FIG. 25.

DETAILED DESCRIPTION

In the following detailed description of exemplary embodiments of theinvention, reference is made to the accompanying drawings, which form apart hereof. The detailed description and the drawings illustratespecific exemplary embodiments by which the invention may be practiced.These embodiments are described in sufficient detail to enable thoseskilled in the art to practice the invention. It is understood thatother embodiments may be utilized, and other changes may be made,without departing from the spirit or scope of the present invention. Thefollowing detailed description is therefore not to be taken in alimiting sense, and the scope of the present invention is defined onlyby the appended claims.

The meaning of “a”, “an”, and “the” include plural references. Themeaning of “in” includes “in” and “on.” Additionally, a reference to thesingular includes a reference to the plural unless otherwise stated orinconsistent with the disclosure herein.

FIG. 3 is a perspective partial-sectional view of a gastroesophagealflap valve restoration assembly 60 including a mold of the normalmovable flap 70 (hereafter “mold”) 70 according to an embodiment of theinvention. The GEFV restoration assembly 60 includes a longitudinalmember 62, an extracorporeal movement control member 64, an endoscopicchannel 66, a pressurized air port 68, a vacuum port 69, a mold 70having a molding surface 72, a tissue shaper 73, a plurality of tissuefixation devices 80 a, 80 c, and 80 e, a plurality of lumens 82 a-e, anda plurality of lumen orifices 84 a-e.

Longitudinal member 62 is a flexible structure dimensioned andstructured for transoral placement into the esophagus and stomach, andincludes the endoscopic channel 66 and the extracorporeal movementcontrol member 64. Endoscopic channel 66 is arranged to at leastpartially surround a length of the shaft of an endoscopic device,maintain an orientation to the shaft, and be movable along the shaft.Longitudinal member 62 also includes the plurality of lumens 82 a-e,each arranged to carry at least one tissue fixation device fordeployment from the orifice of the lumen. FIG. 3 illustrateslongitudinal member 62 carrying tissue fixation devices 80 a, 80 c, and80 e for deployment from the lumen orifices 84 a, 84 c, and 84 e. Inalternative embodiments, greater or fewer lumens 82 may be employed, andone lumen 82 may be arranged to deploy a plurality of tissue fixationdevices 80. In a further alternative embodiment, the tissue fixationdevices 80 may be carried in a chamber or a plurality of chambers, anddeployed from the chambers. Longitudinal member 62 has sufficientflexibility for transoral placement into the stomach, and sufficientrigidity to manipulate structures carried by it. Longitudinal member 62may be made from any material suitable for gastroesophageal surgicaluse, and suitable materials include any biocompatible material known inthe art.

Extracorporeal movement control member 64 is rigidly attached tolongitudinal member 62 and arranged for control of longitudinal androtational movements of the longitudinal member 62, and any structurescarried by it. While control member 64 is illustrated as carryingpressurized air port 66 and vacuum port 69, these ports may be carriedon longitudinal member 62 or any other portion of flap valve restorationassembly 60. Control member 64 may be made from any biocompatiblematerial known in the art.

Mold 70 is carried on the longitudinal member 62, and includes themolding surface 72 and the tissue gripper in the form of the pluralityof tissue gripping vacuum orifices 74. The molding surface 72 has anapproximately 180 degree, semicircular shape related to the normalmovable flap 50 of GEFV 49, and resembles a cupped hand. In anembodiment, the molding surface 72 is formed to replicate the normalgastroesophageal flap 50. Observations of the normal gastroesophagealflap 50 have shown that the appearance, dimensions, and configuration donot vary significantly between people. Molding surface 72 is arranged tomold stomach tissue for fixation, such that when the molded stomachtissue is fixated and released from the mold 70, the molded stomachtissue has a shape and functionality approximating the normalgastroesophageal flap 50 of GEFV 49. Mold 70 is removably carried onlongitudinal member 62, allowing for substitution of another mold 70 ifit is discovered that a different molding surface 72 will provide amolded stomach tissue better approximating a GEFV 49.

In the embodiment illustrated in FIG. 3, the tissue shaper 73 includes aplurality of tissue gripping vacuum orifices 74 that cause stomachtissue to assume a shape related to the normal gastroesophageal flap 50of GEFV 49. The vacuum orifices 74 are disposed on at least a portion ofthe molding surface 72. The vacuum orifices 74 are arranged to draw andurge selected proximate stomach tissue into the mold 70 and to form amolded stomach tissue 125 in a shape related to the normalgastroesophageal flap 50 of GEFV 49 in response to the molding surface72. Vacuum orifices 74 are coupled to a vacuum source by the vacuum port69 and by a vacuum lumen 79. The vacuum level at the vacuum orifices 74is controlled by a regulator (not shown).

Mold 70 has a first configuration for transoral placement into proximityto the gastroesophageal junction, the placement being most likely intothe stomach 43. The first configuration is a collapsed shape sized forthe transoral placement. In an preferred embodiment, the collapsed shapemaintains the endoscopic channel 66 so that the collapsed flap valverestoration assembly 60 may be transorally guided by an endoscope withits distal end placed in the stomach 43. Mold 70 has a secondconfiguration, which has a shape related to the normal gastroesophagealflap 50 of GEFV 49 as illustrated in FIG. 3. Mold 70 is moved from thefirst configuration to the second configuration in vivo. Methods formoving from the first configuration to the second configuration includeapplying pressurized air to inflate mold 70, and a mechanical means. Ifthe mold 70 is moved from the first configuration to the secondconfiguration by applying pressurized air, flap valve restorationassembly 60 includes a pressurized air port 68 and a regulator (notshown) to provide a controlled air pressure, and an inflatable member(not shown). The inflatable member is coupled to the controlled airpressure by an air pressure lumen (not shown), and application of airpressure causes the mold 70 to move from the first configuration to thesecond configuration. Mold 70 is arranged to move from the secondconfiguration to a third configuration for removal from the patient. Thethird configuration may be similar to the first configuration, or may bedissimilar. For example, mold 70 could move from the first configurationto the second configuration like an umbrella being unfolded. Fortransoral removal, mold 70 could then move back to the firstconfiguration, or move to new configuration like an umbrella folded backin the wind. In an alternative embodiment, mold 70 comprises a materialthat may be passed “per vias naturales,” and the third configurationincludes releasing the mold 70 from the longitudinal member 62 into thestomach for passage “per vias naturales.” Mold 70 is made from anybiocompatible material known in the art. When arranged for passage “pervias naturales,” the mold 70 may include a material that is degradableor digestible within the digestive system and passed out of the body, orsimply passed out of the body.

In a preferred embodiment, the portion of the mold having a shaperelated to the GEFV is transparent so the endoscopist may visuallyconfirm the shape of the molded stomach tissue prior to deploying thetissue fixation devices 82. In another alternative embodiment, theplurality of lumens 82 a-e and lumen orifices 84 a-e may be included inthe mold 70 instead of longitudinal member 62.

In an alternative embodiment, the mold 70 may be coupled to anendoscopic device, and the endoscopic device used to maneuver the mold70.

The next series of figures relate to the tissue fixation device, whichis a self-steering and self-closing tissue fixation device in apreferred embodiment. FIG. 4 is a plan view of a self-steering andself-closing tissue fixation device (hereafter “tissue fixation device80”) according to an embodiment of the invention. FIG. 5 is a side viewof the tissue fixation device of FIG. 4 carried in a lumen 82 and in itsinitial stressed and distorted configuration 100, according to anembodiment of the invention. FIGS. 6-9 illustrate sequentialconfigurations of the tissue fixation device 80 as it is deployed andmoves from an initial configuration 100 to a final configuration 115,according to an embodiment of the invention. Tissue fixation device 80includes an elongated member 90, a first end portion 91, a second endportion 92, a connecting portion 93, a tissue-piercing end 94, a firstjoining portion 95, a second joining portion 96, a pressure portion 97,and a push-receiving end 98.

The elongated member 90 includes a biocompatible material havingproperties that allow it to move from a first configuration to a secondconfiguration, typically upon release of a stress or distortion, or upona change in temperature. Suitable materials include materials havingsuperelastic properties, shape memory properties, or both. Thesematerials include Nitinol that has both a shape memory and superelasticproperties, and plastics having shape memory properties. The elongatedmember 90 is formed such that it has an initial stressed and distortedconfiguration 100, and a final configuration 110 arranged to holdtogether tissue enclosed within an interior perimeter 105. The overalllength and thickness of the elongated member 90 are selected to providethe desired fixation by the elongated member 90. For example, the lengthof the portions may be selected depending on the type and thickness ofthe tissue fold 115 to be fixated and the amount of fixation force to beprovided. The thickness of the elongated member 90 may be selected basedon the amount of fixation force to be provided. The thickness may bebetween approximately 0.010 and 0.050 of an inch. Furthermore, thedesired shape of the final configuration 110 may also determine thelength of the portions and the thickness of the material, as well as theamount of bend between the portions in the final configuration 110. Inalternative embodiments, the shape of the final configuration 110 may begenerally rectangular, round, oval or mound. In a further alternativeembodiment, the shape of the final configuration may generally be aspiral.

The initial stressed and distorted configuration 100 is arranged suchthat, as the portions beginning with the first end portion 91 aredeployed from the lumen orifice 84 by a force imparted by push rod 99 onthe push receiving end 98 of the second end portion 92, the superelasticand/or shape memory properties of tissue fixation device 80 steer theelongated member 90 into and through a fold of tissue 115 proximate tothe lumen 84. In an alternative embodiment, the structure from which thetissue fixation device 80 is deployed may be arranged to provide atleast part of the steering of elongated member 80. The deployment oftissue fixation device 80 is illustrated in FIGS. 6-9. Upon beingcompletely pushed from the lumen 82, elongated member 90 self-closes toassumes a final configuration 110 illustrated in FIG. 9. In the finalconfiguration 110, the elongated member 90 forms an interior perimeter105 holding together the fold of tissue 115 that is enclosed within theperimeter. In the final configuration 110, the pressure portion 97opposes the first end portion 91 and the second end portion 92, fixatingthe tissue fold 115 between them. The interior perimeter 105 of thefinal configuration 110 may close only to the degree necessary toprovide the desired fixation. In an alternate embodiment, the first endportion 91 is proximate to second end portion 92 in the finalconfiguration 110 as illustrated in FIG. 9. In a further alternativeembodiment, the elongated member 90 forms a substantially enclosedperimeter in the final configuration 110.

FIG. 10 is a perspective cross-sectional view of the GEFV restorationassembly 60 of FIG. 3 being used to transorally restore agastroesophageal flap valve employing an endoscopic visualization device120, according to an embodiment of the invention. Endoscopicvisualization is used in a preferred embodiment of restoring a GEFV. Inother preferred embodiments, other visualization techniques may be usedsuch as a fluoroscope or a swallowable camera. As shown in FIG. 10, afirst step in transorally restoring a GEFV includes advancing a flexibleendoscope 120 into the stomach 43 by way of the esophagus 41. Theendoscope 120 is retroflexed so that the viewing element in the distalend 122 shows the area where the esophagus 41 joins the stomach 43.Viewing endoscopes are well known in the art, and are typically equippedwith a lighting element and a viewing element enabling the operator toview the interior of a body cavity, such as the stomach 43 in this case.For the purposes of the embodiment of the invention illustrated in FIG.10, the endoscopic visualization device (hereafter “endoscope”) 120 maybe an instrument separate from the other devices used to transorallyrestore a gastroesophageal flap valve. The endoscope 120 may workcooperatively with the other devices used to transorally restore agastroesophageal flap valve, for example guiding the longitudinal member62.

In an initial step, the longitudinal member 62 carrying the mold 70 isslid over the shaft of the endoscope 120 and placed near the proximalend of the endoscope 120. In another step, the viewing element of distalend 122 of the endoscope 120 is placed into the stomach 43, andretroflexed to provide viewing of the area where the esophagus 41 joinsthe stomach 43. The GEFV mold 70, in its first configuration fortransoral placement, is lowered into the stomach 43 by sliding thelongitudinal member 62 along the shaft of the endoscope 120 as a guide.Once in the stomach 43, the GEFV 70 mold is moved from its firstconfiguration to its second configuration having a shape related to theGEFV 49. Another step includes moving the mold 70 (in its secondconfiguration) along the shaft of the endoscope 120 upward toward thepatient's head and the esophagus 41 in the direction indicated bymolding movement arrow 123, to a position where the mold 70 is proximateto the deteriorated gastroesophageal flap 55 (not shown) and a portionof the fundus 46 proximate to the cardiac notch 47. This movement isperformed under visualization with the endoscope 120. A vacuum isapplied to the vacuum lumen 79 and to the plurality of tissue grippingvacuum orifices 74. The vacuum orifices 74 grip, urge, and draw in afold of musculo-mucosal tissue 115 into the mold 70, and hold the foldof tissue 115 against the molding surface 72. This molds the fold oftissue 115 into a shape related to a gastroesophageal flap (hereafter“molded stomach tissue”) 125, such as the normal gastroesophageal flap50 of GEFV 49. Typically, the fold of tissue 115 will include tissue ofthe wall of the fundus 46 near the cardiac notch 47 folded against theadjacent portion of the esophagus 41. While the fold of tissue 115 isillustrated as a fold of an entire thickness of tissue, the fold oftissue 115 may include less than the entire thickness of tissue, such asone or two layers. Prior to fixating the molded stomach tissue 125, themolded stomach tissue 125 may be viewed through a transparent portion ofthe mold 70 with the endoscope 120 to confirm that it meets theexpectations of the endoscopist.

To fixate and secure the molded stomach tissue 125 in a shapeapproximating a gastroesophageal flap valve, at least one tissuefixation device 80 is deployed from the lumen orifice 84 in the mannerdescribed in conjunction with FIGS. 5-9. The tissue fixation devices 80are typically preloaded into the lumens 82 of longitudinal member 62prior to insertion of the mold 70 into the stomach 43. Typically, morethan one tissue fixation device 80 is used. In an alternativeembodiment, the tissue fixation devices 80 are deployed in a pattern toprovide optimal fixation, such as an “M” or “C” or any other pattern,which may be repeated. In an alternative embodiment, the tissue fixationdevice is glue, or a substance provoking tissue regeneration oradhesion, which may be deployed individually, or in association with themechanical tissue fixation devices 80. When used in association, theglue or provoking substance may be deposited between the tissues of thefold of tissue 115 to more firmly attach the tissues to each other, toincrease the area of adhesions to improve the fixation, and to seal offthe fixation sites.

Another step includes moving the mold 70 along the shaft of theendoscope 120 downward opposite to arrow 123, and toward the patient'sfeet and away from the esophagus 41 and the restored gastroesophagealflap valve, to a position where the fixated molded stomach tissue 125may be inspected with the distal end 122 of the endoscope 120. If uponinspection the endoscopist is not satisfied that an acceptable restoredgastroesophageal flap 127 has been formed, the mold 70 may be moved backinto position for placement of additional tissue fixation devices 80, orfor creating an additional molded tissue 125 and fixating.

A final step includes removal of the mold 70 from the patient. The mold70 is moved from the second configuration to a third configuration fortransoral removal, and removed from the patient by removing thelongitudinal member 62. In an alternative embodiment, mold 70 comprisesa material that may be passed “per vias naturales,” i.e., by a naturalprocess. The mold 70 is released from the longitudinal member 62 intothe stomach for passage “per vias naturales,” and the longitudinalmember 62 is removed from the patient. In another alternativeembodiment, the mold 70 can be left engaged temporarily with the fixatedmolded stomach tissue 125 to support the function of the restored GEFV129, and protect it during healing. The mold 70 is arranged todisintegrate within a predetermined over time.

The steps described above are expected to result in a relativelyuniformly shaped fold of tissue 115 because the mold 70 establishes thesize of the fold of tissue 115 and molds the fold of tissue 115 into themolded stomach tissue 125 that approximates a normal gastroesophagealflap 50. The endoscopist does not need to decide how much tissue to taketo form the fold of tissue 115 because the mold 70 standardizes andestablishes these parameters.

The above procedure may also be performed with the longitudinal member62 and the mold 70 being used in conjunction the endoscope 120, but notbeing moved over or physically guided by the shaft of the endoscope 120.In alternative embodiments, other visualization methods may be used,such as fluoroscopy with appropriate viewing marks on the devices.

FIG. 11 is a perspective cross-sectional view of a restoredgastroesophageal flap 127 and a restored GEFV 129 according to anembodiment of the invention. FIG. 11 illustrates the restoredgastroesophageal flap 127 formed by an embodiment of the inventiondescribed in conjunction with FIG. 10, after the mold 70 and thelongitudinal member 62 have been removed from the vicinity of thegastroesophageal junction. At least one tissue fixation device 80, andpreferably a plurality of tissue fixation devices 80, maintains themolded stomach tissue 125 as the restored gastroesophageal flap 127. Therestored gastroesophageal flap 127 approximates the movement andfunctionality of the normal gastroesophageal flap 50. It opens andcloses against the lesser curvature 45 portion of the stomach 43 in themanner of the normal gastroesophageal flap 50 described in conjunctionwith FIG. 1, thus forming a restored GEFV 129. The restored GEFV 129 isexpected to approximate the functionality of the normal GEFV 49described in conjunction with FIG. 1. The molding process described inconjunction with FIG. 10 is expected to produce a highly standardizedprocedure and outcome. Another advantage of the molding process is thatthe functionality of the normal GEFV 49 is reestablished upon conclusionof the procedure. There is no need to wait for adhesion to form a flap,or for a mounting device to biodegrade.

In addition to creating a restored gastroesophageal flap 127 and arestored GEFV 129, the embodiment of the invention described inconjunction with FIG. 10 also restores at least some of the otherdeteriorations associated with GERD that are illustrated in FIG. 2. Thecreation of the restored GEFV 125 also at least partially restores thecardiac notch 47 and makes the Angle of His 57 more acute. This movesthe superior portion of the fundus 46 toward the mouth and away fromwhere the esophagus 41 enters the stomach 43, restoring the arch of thenormal fundus 46. This is expected to restore a patient's ability toburp air and gas. This is further expected to reduce the degree to whichstomach contents reflux into the esophagus because the stomach contentsare no longer presented with a funnel-like structure into the esophagus41, as is the case with a Grade III or IV reflux appearancegastroesophageal flap 55.

FIG. 12 is a perspective partial cross-section view of an invaginatordevice 130 according to an embodiment of the invention. The invaginatordevice 130 includes an invaginator longitudinal member 132, aninvaginator extracorporeal movement control member 134, an endoscopechannel 136, a pressurized air port 138, a vacuum port 139, aninvaginator-longitudinal member coupler 140, an invaginator surface 142,a longitudinal raised portions 143, a plurality of tissue grippingvacuum orifices 144, an invaginator member 146, an inflation member 147,an air pressure lumen 148, and a plurality of vacuum lumens 149.

The invaginator assembly 130 is a flexible structure arranged forgripping the walls of body lumens and hollow body structures, such asthe esophagus and intestines. It is also arranged for endoscopicplacement. The endoscope channel 136 of longitudinal member 132 isarranged to at least partially surround a length of the shaft of anendoscopic device, maintain an orientation relative to the shaft, and bemovable along the shaft. While the invaginator device 130 has broadapplication for use with any body lumen or hollow structure, itsfeatures will be described with respect to a preferred embodiment forinvaginating esophageal tissue in conjunction with restoration of aGEFV. Invaginator assembly 130 is arranged for transoral, endoscopicplacement into the esophagus, and includes the endoscope channel 136 andthe extracorporeal movement control member 134. In addition to beingarranged to surround a length of the shaft of an endoscopic device, theendoscope channel 136 is also arranged to at least partially surround alength of the longitudinal member 62 of flap valve restoration assembly60 illustrated in FIG. 3, maintain an orientation to the longitudinalmember 62, and be movable along the longitudinal member 62. Longitudinalmember 132 has sufficient flexibility for transoral placement into thestomach, and sufficient rigidity to manipulate structures carried by itand moved in opposition to it. Longitudinal member 62 may be made fromany biocompatible material known in the art.

The extracorporeal invaginator movement control member 134 is attachedto longitudinal member 132 and arranged to control the movements of thelongitudinal member 132 and devices carried by it, including theinvaginator member 146. Control member 134 includes a pressurized airport 138 and a vacuum port 139. While the control member 134 isillustrated as carrying the pressurized air port 138 and the vacuum port139, these ports may be carried on the invaginator longitudinal member132 or any other portion of the invaginator assembly 130. The controlmember 134 may be made from any biocompatible material known in the art.

The invaginator member 146 and its components are coupled to theinvaginator longitudinal member 132 by the invaginator-longitudinalmember coupler 140. The invaginator member 146 may have any shape. In apreferred embodiment, the invaginator member 146 is a generallycylindrical shape for ease of transoral insertion, and includes aninflation member 147, an air pressure lumen 148, and a vacuum lumen 149.The invaginator member 146 also includes an invaginator surface 142having a plurality of longitudinal raised portions 143. At least onelongitudinal raised portion 143 has a tissue gripper in the form of theplurality of tissue gripping vacuum orifices 144 served by a vacuumlumen 149 underlying the longitudinal raised portion 143. Only onelongitudinal raised portion 143 is provided reference numbers in FIG. 12for clarity. The plurality of tissue gripping vacuum orifices 144 arearranged to grip tissue by drawing, and tightly and releasably engagingthe esophageal wall with the invaginator member 146. Once engaged, theinvaginator assembly 130 can be used to impart a force to the vacuumgripped esophagus tissue to urge the engaged portion of the esophagus 41in a direction selected by the endoscopist. The tissue gripping vacuumorifices 144 are coupled to a vacuum source by the vacuum port 139 andby a vacuum lumen 149. The vacuum level at the tissue gripping vacuumorifices 144 is controlled by a regulator (not shown). In an alternativeembodiment, the invaginator member 146 may be only a portion of agenerally cylindrically shaped structure. For example, the invaginatormember 146 may be carried on the longitudinal member 63 of FIG. 3, andarranged to only engage approximately one-half of the interior perimeterof the esophagus. In an alternative embodiment, the invaginator tissuegripper may comprise a peripheral surface arranged to non-invasively andfrictionally engage tissue, such as a fish scale-like structure similarto that used on the bases of cross country skis, or a plurality ofprotrusions.

Invaginator member 146 has a first configuration for transoral placementthrough the mouth, down into the esophagus, and into proximity to theLES 48. The first configuration is a collapsed shape dimensioned fortransoral placement. In a preferred embodiment, the collapsed shapemaintains the endoscopic channel 136 so that the collapsed invaginatormember 146 may be transorally guided by an endoscope shaft. Invaginatormember 146 has a second configuration, which has a shape related to thecross-sectional dimensions of the esophagus 41. Invaginator member 146is moved from the first configuration to the second configuration invivo. Methods for moving from the first configuration to the secondconfiguration include applying a pressure to expand the inflation member147, and a mechanical means. The pressure can be supplied by compressedair or pressurized fluid. An embodiment of the invention is illustratedthat includes application of air pressure to expand the inflation member146 by inflation, and move the invaginator member 146 from a firstconfiguration to a second configuration. The invaginator device 130includes a pressurized air port 138, a regulator (not shown) to providea controlled air pressure, and an inflation member 147. The inflationmember 147 is coupled to the controlled air pressure by an air pressurelumen 148, and application of air pressure causes the invaginator member146 to move from the first configuration to the second configuration.The invaginator member 146 is arranged to move from the secondconfiguration to a third configuration for removal from the patient. Themovement to the third configuration may be by releasing the air pressurefrom the inflation member 147. The third configuration may be similar tothe first configuration. The invaginator member 146 is made from anybiocompatible material known in the art. In an alternative embodiment,the invaginator device 130 may be coupled to an endoscopic device, andthe endoscopic device used to maneuver the invaginator device 130.

FIG. 13 is a perspective cross-sectional view of the GEFV restorationassembly 60 of FIG. 3 and the invaginator assembly 130 of FIG. 12 beingused to transorally restore a gastroesophageal flap valve employing anendoscopic visualization device 120, according to an embodiment of theinvention. FIG. 13 illustrates the invaginator device 130 providingmovement of and control over the esophagus 41 in combination with theGEFV restoration assembly 60 for transoral restoration of agastroesophageal flap valve. The portions toward the patient's mouth ofthe shaft of the endoscope 120, the invaginator longitudinal member 132,and the longitudinal member 62 are truncated in FIG. 13 for clarity. Theprocedure is similar to that described in conjunction with FIG. 10.Preferably, prior to moving the mold 70 toward to the patient's head inthe direction of arrow 123, the invaginator device 130 with theinvaginator member 146 in its first configuration for placement islowered into the esophagus 41. The invaginator longitudinal member 132is engaged with and slid along the shaft of the endoscope 120 and thelongitudinal member 62 of the GEFV restoration assembly 60 as a guide toa position preferably toward the patient's mouth from the LES 48.

Invaginator member 146 is then moved in vivo from the firstconfiguration to the second configuration by application of air pressureto the inflation member 147 for vacuum engagement of the esophagus.Another step includes application of a vacuum to the vacuum lumen 149and correspondingly to the plurality of tissue gripping vacuum orifices144 in the longitudinal raised portions 143. In response to the appliedvacuum, the plurality tissue gripping vacuum orifices 144 draw in, andtightly and releasably engage the esophageal wall with the invaginatormember 146. A force in the invagination movement direction 162 isapplied to invaginator extracorporeal movement control member 134 topush the lower portion of esophagus 41 and the gastroesophageal junction52 (not shown) toward and partially invaginated into the stomach 43.This moves stomach tissue generally, and particularly a portion of thefundus 46, into an improved position for restoration of the GEFV. Theinvagination aids in creating the fold of tissue 115 by partiallypre-forming the fundus tissue, and by improving the position andpresentment of the fundus tissue to the mold 70. The endoscopist islikely to need the invaginator device 130 to create the fold of tissue115 when a Grade IV GEFV is being restored. The invaginator device 130may not be needed when a Grade II or Grade III GEFV is being restored.Once a restored GEFV 129 has been formed, the invaginator member 146 ismoved from the second position to the third position for removal, andthe invaginator device 130 is removed from the patient.

The next three figures illustrate another gastroesophageal flap valverestoration device according to another embodiment of the invention.FIGS. 14 and 16 are perspective partial-sectional views of agastroesophageal flap valve restoration assembly 200 with a moveabletissue gripper, according to an embodiment of the invention. FIG. 14illustrates GEFV restoration assembly 200 with the moveable tissuegripper 210 in its extended configuration. FIG. 15 is a cross-sectionalplan view of the mold 230 of FIG. 14. FIG. 16 illustrates GEFVrestoration assembly 200 with the moveable tissue gripper 210 in itsretracted/molding configuration. GEFV restoration assembly 200 includesa longitudinal member 202, an endoscopic channel 66, a non-invasivetissue gripper 210, a tissue gripper control member 211, a vacuum port139, a movable arm 212, a plurality of tissue gripping orifices 214, avacuum gripping surface 216, a bending portion 218, a mold 230, abending guide surface 232, and a molding surface 234. FIGS. 14 and 16 donot illustrate the extracorporeal portions of the endoscope 120 and thelongitudinal member 202, which are truncated for clarity.

Longitudinal member 202 is substantially similar to longitudinal member62 of GEFV restoration assembly 60 described in conjunction with FIG. 3.The longitudinal member 202 carries the mold 230 and the moveable arm212 on its distal end for placement within the stomach. For purposes ofclarity, FIGS. 14 and 16 do not illustrate the plurality of lumens 82a-e arranged to carry tissue fixation devices 80 for deployment from theplurality of lumen orifices 84 a-e, and do not illustrate theextracorporeal movement control member 64.

The tissue gripper 210 includes the tissue gripper control member 211,the vacuum port 139, the moveable arm 212, the plurality of tissuegripping vacuum orifices 214, the vacuum gripping surface 216, and thebending portion 218. The tissue gripper control member 211 is carried ina lumen (not shown) in longitudinal member 202. The bending portion 218joins the tissue gripper control member 211 and the moveable arm 212,and is arranged to bend over a range of about 90 degrees. The arm 212carries vacuum gripping surface 216, which in turn carries the pluralityof tissue gripping vacuum orifices 214. The tissue gripping vacuumorifices 214 are vacuum coupled to the vacuum port 139 by a vacuum lumen(not shown) running through the moveable arm 212, the bending portion218, and the control member 211. In an alternative embodiment, thevacuum coupling may include a vacuum lumen that bypasses the bendingportion 218. The plurality of tissue gripping vacuum orifices 214 arearranged to grip tissue by drawing in, and tightly and releasablyengaging proximate tissue with the vacuum gripping surface 216. Onceengaged, the tissue gripper 210 can be used to impart a force to thevacuum gripped tissue to urge the gripped tissue and surrounding tissuein a manner selected by the endoscopist.

The moveable arm 212 of the tissue gripper 210 is arranged to be movableby moving control member 211 longitudinally relative to the longitudinalmember 202. FIG. 14 illustrates the tissue gripper 210 with the moveablearm 212 in an extended configuration for gripping tissue. FIG. 16illustrates the moveable arm 212 of the tissue gripper 210 in theretracted/molding configuration. The moveable arm 212 is moved from theextended configuration of FIG. 14 to the retracted/molding configurationillustrated in FIG. 16 by moving tissue gripper control member 211distally and longitudinally toward the mold 230. The movement of controlmember 211 distally forces the moveable arm 212 against bending guidesurface 232, which in turn exerts a bending force against bendingportion 218. Continued movement of control member 211 increases the bendin the bending portion 218 and moves the moveable arm 212 to theretracted/molding configuration. The bending guide surface 232 isarranged to control the position of the moveable arm 212 relative to thelongitudinal member 202, so that the moveable arm 212 in theretracted/molding configuration holds the fold of tissue 115 proximateto the longitudinal member 202 and drawn into and against the moldingsurface 234. The extension of moveable arm 212 is by moving the controlmember 211 proximally. The tissue gripper 210 is arranged tonon-invasively grip and move a fold of tissue 115 into the mold 230. Thetissue gripper 210 brings the tissues in the fold of tissue 115 closetogether for fixation. In an alternative embodiment, the moldingconfiguration of the moveable arm 212 includes moving the vacuumgripping surface 216 an additional distance distally to a position wherethe vacuum gripping surface 216 is distal of the bending guide surface232. In an alternative embodiment, the tissue gripper 210 can bearranged to draw a fold of tissue 115 into the mold 70 of FIG. 3 bymaking provision for and carrying the tissue gripper 210 withlongitudinal member 62.

FIG. 15 illustrates the mold 230 carried on the distal end of thelongitudinal member 202. Endoscope 120 and tissue gripper 210 areomitted from FIG. 15 for clarity. The mold 230 is a semicircularstructure that includes the bending guide surface 232 and the moldingsurface 234, and is arranged for causing stomach tissue to assume ashape related to a gastroesophageal flap. The molding surface 234 has anapproximately 180 degree, semicircular shape related to the normalgastroesophageal flap 50. In alternative embodiments, the moldingsurface 234 may be configured to form a semicircular structure havingwith a semicircular arc varying between approximately 90 degrees and 360degrees. The molding surface 234 is arranged to have a fold of tissue115 drawn into it by the tissue gripper 210, thereby molding that foldof tissue 115 into molded stomach tissue 125. The molding surface 234 isformed to replicate the normal gastroesophageal flap 50. In analternative embodiment, the mold 230 has a first collapsed configurationfor transoral placement into the stomach 43, and a second configurationhaving a shape related to the gastroesophageal flap.

FIGS. 17-22 are schematic cross-sectional views illustrating the GEFVrestoration assembly with tissue gripper 200 of FIGS. 14-16 being usedto transorally restore a gastroesophageal flap valve, according to anembodiment of the invention. The restoration is similar to thatdescribed in conjunction with FIG. 10, and uses the endoscope 120 forvisualization and as a guide for placing the distal end of thelongitudinal member 202 in the stomach 43. FIG. 17 illustrates aninitial step where the distal portion of the longitudinal member 202carrying the tissue gripper 210 and the mold 230 is placed in thestomach 43. The moveable arm 212 is in a first configuration forinsertion, which is the retracted/molding configuration.

FIG. 18 illustrates an intermediate step where the moveable arm 212 ismoved from the first retracted/molding configuration position to thesecond gripping configuration for gripping and moving a fold of tissue115. The movement of the moveable arm 212 is by manipulation of thetissue gripper control member 211. Under visualization of the endoscope120, the moveable arm 212 is placed in proximity to target tissue of thefundus 46 that is proximate to the cardiac notch 47 and selected by theendoscopist as suitable for restoration of the GEFV 49. A vacuum isapplied to the tissue gripping vacuum orifices 214, causing the vacuumgripping surface 216 to grip the target tissue by vacuum drawing in, andtightly and releasably engaging the target tissue. The vacuum grippedtarget tissue and tissue proximate to it form the fold of tissue 115.

FIG. 19 illustrates an intermediate step where the moveable arm 212,while vacuum gripping the target tissue, is partially moved from thesecond gripping configuration to the first retracted/moldingconfiguration and toward the mold 230. FIG. 20 illustrates anotherintermediate step where the moveable arm 212, while vacuum gripping thetarget tissue, is moved further to the first retracted/moldingconfiguration and partially into the mold 230.

FIG. 21 illustrates still another intermediate step where the moveablearm 212, while vacuum gripping the target tissue, has been moved to thefirst retracted/molding configuration and fully into the mold 230. Uponbeing moved fully into the mold 230 as illustrated by FIG. 21, themolding surface 234 of mold 230 brings the tissues comprising the foldof tissue 115 close together, and causes the fold of tissue 115 toassume a shape related to a gastroesophageal flap (molded stomach tissue125). The fold of tissue 115 does not include the gastroesophagealjunction 52 or any tissue oral of the gastroesophageal junction 52. Tofixate and secure the molded stomach tissue 125, at least one tissuefixation device 80 is deployed from the lumen orifice 84 (not shown) inthe manner described in conjunction with FIGS. 5-9, and 10. The fixationmaintains the shaped stomach tissue in a shape approximating agastroesophageal flap (restored gastroesophageal flap 127) asillustrated in FIG. 11. FIG. 22 illustrates a final step where the mold230 and moveable arm 212 are moved distally into the stomach 43 forinspection by the endoscopist. A final step includes removal of the mold230 and the moveable arm 212 from the patient.

FIG. 23 is a perspective partial-sectional view of a gastroesophagealflap valve restoration assembly 250 with a tissue gripper guide in itsretracted/molding configuration, according to an embodiment of theinvention. The gastroesophageal flap valve restoration assembly 250 issimilar in construction and operation to the flap valve restorationassembly 200. The restoration assembly 250 includes a guide support 254and a guide surface 256, but does not include the mold 230 of FIG. 14.The restoration assembly 250 uses the tissue gripper 210 as a tissueshaper to cause stomach tissue to assume a shape related to agastroesophageal flap 50. Guide support 254 is carried on longitudinalmember 202, and the guide surface 256 is arranged to control theposition of the moveable arm 212 relative to the longitudinal member202, so that the moveable arm 212 in the retracted/molding configurationholds the fold of tissue 115 proximate to the longitudinal member 202.

FIG. 24 is a cross-sectional view illustrating the gastroesophageal flapvalve restoration assembly 250 of FIG. 23 being used to transorallyrestore a gastroesophageal flap valve, according to an embodiment of theinvention. Restoration of the gastroesophageal flap with thegastroesophageal flap valve restoration assembly 250 is similar to therestoration of the gastroesophageal flap with the flap valve restorationassembly 200 described in conjunction with FIGS. 17-22. The restorationbegins to differ at FIG. 21, the point where the moveable arm 212 is inthe retracted/molding configuration and is holding the fold of tissue115 proximate to the longitudinal member 202 in an initial shapingposition 258. As illustrated in FIG. 24, the longitudinal member 202 andthe movable arm 212 become the tissue shaper of this embodiment, andcause the gripped stomach tissue to assume a shape related to agastroesophageal flap. A plurality of tissue gripping steps is used tocause the fold of tissue 115 to assume a shape related to agastroesophageal flap. At least one tissue fixation device 80 isdeployed into the fold of tissue 115 at the initial shaping position258. The vacuum applied to the plurality of tissue gripping vacuumorifices 214 is reduced to disengage the vacuum gripping surface 216from the fold of tissue 115, and the moveable arm 212 may be moved awayfrom the fold of tissue 115. The longitudinal member 202, which carriesthe tissue gripper 210 and the guide support 254, is rotated to anothershaping position 259. The vacuum is reapplied to the plurality tissuegripping vacuum orifices 214 to engage the vacuum gripping surface 216with the fold of tissue 115, and the movable arm 212 is moved toretracted/molding configuration. At least one tissue fixation device 80is deployed into the fold of tissue 115 at the another shaping position259. The movement, shaping, and fixation of tissue in a shapeapproximating a gastroesophageal flap continues until a restoredgastroesophageal flap 127 is formed. The restoration is viewed from aretroflexed endoscope, and the endoscopist is able to inspect each step.Once the endoscopist is satisfied that a restored GEFV 49 has beenformed, as illustrated in FIG. 1, a final step includes removal of thegastroesophageal flap valve restoration assembly 250 from the patient.

FIG. 25 is perspective partial-sectional view of a gastroesophageal flapvalve restoration assembly of FIGS. 14-16 arranged to engage anextracorporeal portion of an endoscopic device when a portion of theendoscopic device is in vivo, according to an embodiment of theinvention. FIG. 26 is a perspective partial cross-sectional view ofgastroesophageal flap valve restoration assembly 300. Gastroesophagealflap valve restoration assembly 300 includes a longitudinal member 302,which includes a retention portion 304, and in an alternative embodimentat least one other retention portion 306.

The endoscopic channel 66 of longitudinal member 302 is round but doesnot close along its length, allowing the restoration assembly 300 to beremovably engaged with a portion of the shaft of an endoscopic device120 when the retroflexed end 122 is in vivo. The endoscopic channel 66of longitudinal member 302 is dimensioned to partially surround a lengthor a portion of a shaft of an endoscopic device 120. The retentionportions 304 and 306 are arranged to allow longitudinal member 302 toengage the shaft of an endoscopic device 120, to retain the engagementuntil disengaged by the endoscopist, and to allow the longitudinalmember 302 to be moveable relative to the shaft of the engaged endoscope120. In an alternative embodiment, the gastroesophageal flap valverestoration assembly 300 includes a plurality of longitudinal shims tomatch the diameter of the endoscopic channel 66 to the diameter of theendoscope shaft.

The ability to engage the longitudinal member 302 of gastroesophagealflap valve restoration assembly 300 with the shaft of an endoscope 120allows an endoscopist to first endoscopically view the stomach 43 andGEFV 49 to determine whether restoration is indicated. When restorationis indicated, the endoscopist can then engage the longitudinal member302 with the shaft of the endoscope 120 without removing the retroflexedtip (distal end) of the endoscope 122 from the stomach 43. Thegastroesophageal flap valve restoration assembly 300 is then moved downthe shaft of the endoscope 120 and into position for restoration of thegastroesophageal flap.

The arrangement providing an ability to engage a longitudinal member ofa gastroesophageal flap valve restoration assembly with an endoscopewithout removing the retroflexed tip of the endoscope from the stomachmay be used for any of the devices described herein. Extracorporealmovement control members, such as member 64 of FIG. 3, may require anopening to allow the shaft of the endoscope 120 to fully enter theendoscopic channel 66.

Although the present invention has been described in considerable detailwith reference to certain preferred embodiments, other embodiments arepossible. Therefore, the spirit or scope of the appended claims shouldnot be limited to the description of the embodiments contained herein.It is intended that the invention resides in the claims hereinafterappended.

1-70. (canceled)
 71. A method of forming a flap in a lower portion ofthe esophageal tract, comprising the steps of: providing a device havinga tissue holding element; advancing the device into an esophageal tractof a patient; engaging a portion of the stomach with the device;applying a force to displace the portion of the stomach toward thepatient's feet; moving a first tissue layer and a second layer togetherto create a fold of tissue, the fold of tissue including a layer of thestomach and a layer of the esophageal tract and the intersection of thestomach and the esophageal tract; holding the first and second tissuelayers together using the tissue holding element after applying thestep; and attaching the first and second tissue layers together whileholding the first and second tissue layers together.
 72. The method ofclaim 71, wherein the moving step is carried out with the intersectionbetween the stomach and the esophageal track being formed by the fold oftissue.
 73. The method of claim 71, wherein the applying step is carriedout before completing the moving step so that the portion of the stomachis displaced toward the feet before forming the fold of tissue.
 74. Themethod of claim 71, wherein the providing step is carried out with thedevice including a tissue gripping element having a vacuum orifice togrip the esophageal tract.
 75. The method of claim 74, furthercomprising the step of imparting a force to the esophageal tract whilethe vacuum orifice grips the esophageal tract.
 76. The method of claim75, wherein the imparting step is carried out before the moving step tomove tissue into an improved position for forming a flap from the foldof tissue.
 77. The method of claim 71, wherein the providing step iscarried out with the tissue griping element being movable relative tothe tissue holding element.